The Effect of β-hydroxy-β-methylbutyrate Supplementation on Physical Capacity and Body Composition in Trained Athletes

NCT03028649 | Completed Phase 3

• 1 other identifier: NN312262340
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to verify the effect of 12-week with β-hydroxy-β-methylbutyrate (HMB) and a placebo (PLA) supplementation on body composition, anaerobic and aerobic capacity, as well as concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Conditions

Sport; Supplements; Supplementation

Keywords

β-hydroxy-β-methylbutyric acid; Sport supplements; Training support; Adaptation

Outcome Measures

Primary Outcomes (10)

• Changes of body composition indices after HMB supplementation

  Analysis of the fat mass and fat free mass

  Baseline and after 12 weeks

• Changes of body composition indices after placebo treatment

  Analysis of the fat mass and fat free mass

  Baseline and after 12 weeks

• Changes of aerobic capacity after HMB supplementation

  Baseline and after 12 weeks

• Changes of aerobic capacity after placebo treatment

  Baseline and after 12 weeks

• Changes of anaerobic capacity after HMB supplementation

  Baseline and after 12 weeks

• Changes of anaerobic capacity after placebo treatment

  Baseline and after 12 weeks

• Changes of creatine kinase and lactate dehydrogenase activity in blood after HMB supplementation

  Baseline and after 12 weeks

• Changes of creatine kinase and lactate dehydrogenase activity in blood after placebo treatment

  Baseline and after 12 weeks

• Changes of testosterone, cortisol and lactate levels in blood after HMB supplementation

  Baseline and after 12 weeks

• Changes of testosterone, cortisol and lactate levels in blood after placebo treatment

  Baseline and after 12 weeks

Secondary Outcomes (4)

• Statistical evaluation of the significance of differences between the changes in body composition (fat mass and fat free mass)

  1 year

• Statistical evaluation of the significance of differences between the changes in aerobic capacity indices

  1 year

• Statistical evaluation of the significance of differences between the changes in anaerobic capacity indices

  1 year

• Statistical evaluation of the significance of differences between the changes in creatine kinase and lactate dehydrogenase activity and testosterone, cortisol and lactate levels in blood

  1 year

Study Arms (2)

β-hydroxy-β-methylbutyrate (HMB)

EXPERIMENTAL

Group taking oral supplementation with calcium salt of β-hydroxy-β-methylbutyric acid produced by Olimp Laboratories. A single capsule contained 1250 mg Ca-HMB, which corresponds to 1000 mg of β-hydroxy-β-methylbutyrate. Interventions: The experimental procedure for each athlete included a 12-week HMB supplementation - 3 capsules of the assigned preparation a day in 3 doses: upon waking, immediately after training, and before sleep. On non-training days, the participants were instructed to consume one serving with each of three separate meals throughout the day. Between the 12-week HMB and PLA or a PLA and HMB treatment, a 10-day washout period was introduced.

Dietary Supplement: β-hydroxy-β-methylbutyrate and a placebo supplementation

Placebo (maltodextrin)

PLACEBO COMPARATOR

Group taking oral supplementation with placebo (maltodextrin). A single capsule contained 1000 mg of maltodextrin. Interventions: The experimental procedure for each athlete included a 12-week placebo administration - 3 capsules of the assigned preparation a day in 3 doses: upon waking, immediately after training, and before sleep. On non-training days, the participants were instructed to consume one serving with each of three separate meals throughout the day. Between the 12-week HMB and PLA or a PLA and HMB treatment, a 10-day washout period was introduced.

Dietary Supplement: β-hydroxy-β-methylbutyrate and a placebo supplementation

Interventions

β-hydroxy-β-methylbutyrate and a placebo supplementation DIETARY_SUPPLEMENT

Placebo (maltodextrin); β-hydroxy-β-methylbutyrate (HMB)

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• written consent to participate,
• male
• a current medical clearance to practice sports,
• training experience: at least 5 years,
• minimum of 6 workout sessions a week (minimum 3 in the practiced sports discipline).

You may not qualify if:

• current injury,
• any health-related contraindication,
• declared general feeling of being unwell,
• unwilling to follow the study protocol.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead
• Poznan University of Life Sciences: collaborator
• National Science Centre, Poland: collaborator

Study Sites (1)

Poznan University of Life Sciences, ul.Wojska Polskiego 31

Poznan, Wielkopolska, 60-624, Poland

Location

Study Officials

• Jan Jeszka, Professor

  Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 23, 2017
• Study Start: January 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

PL (1)